FDA Proposes New Guidelines to Ensure Pulse Oximeters Accurately Measure Oxygen Levels in People of Colour

Medical device manufacturers may soon need to collect additional data to demonstrate the effectiveness of their products for patients of colour. This follows a new proposal from the Food and Drug Administration (FDA) released on Monday. The guidelines focus on pulse oximeters, which are used in healthcare settings to monitor oxygen levels in patients' blood.

The FDA's recommendations aim to address potential racial biases in medical technology. Pulse oximeters, which clip onto a finger and use light to estimate blood oxygen levels, have been found less accurate for individuals with darker skin tones. This issue gained attention during the COVID-19 pandemic when these devices were crucial for patient care.

FDA's Proposed Testing Guidelines

The FDA suggests several changes to how companies should test pulse oximeters. These include enrolling at least 150 patients with varied skin tones in clinical studies and ensuring that at least 25% of participants have darker skin. Additionally, pigmentation should be assessed using two methods: a researcher's evaluation and a scientific measurement of melanin levels.

These recommendations apply only to professional oximeters used in hospitals and clinics. Over-the-counter oximeters, considered "general wellness" devices, are not regulated by the government. The FDA's draft guidelines will not affect existing devices but will require diversity data for any updates or changes manufacturers seek approval for.

Addressing Racial Biases in Medical Devices

Concerns about racial biases in medical technology have led to multiple FDA meetings and studies since 2022. In 2021, the FDA warned about potential inaccuracies in pulse oximeter readings for Black patients after studies showed these devices often overestimated their oxygen levels. Such inaccuracies could delay treatment and increase health risks.

The FDA's draft recommendations are not yet binding. The agency will accept public comments on the proposal for 60 days before working on a final version. This initiative highlights the ongoing efforts to ensure medical devices are effective across diverse populations.

While the proposed guidelines do not mandate changes to older devices currently in use, they signal the FDA's expectation for manufacturers to provide new diversity data when seeking approval for modifications or updates to existing oximeters.